PDA - Parenteral Drug Association

The national, regional and often site-specific regulations governing sterile manufacturing are challenging for even the most experienced manufacturing professional. Keeping track of so many variations and ensuring compliance with manufacturing activities across regions is an absolute must for international pharmaceutical manufacturing professionals and the companies they represent. We want to hear from you! This topic is the main focus of our GMP Comparison Workshop, based on PDA’s newly revised Global Sterile Manufacturing Regulatory Guidance Comparison Book and its updated comparison toolset. This workshop brings forward the regulations and information you need to ensure compliance with Good Manufacturing Practice (GMP) for any country or region where products are manufactured. Learn more at pda.org/gmp2024 #sterilemanufacturing #GMP #pharma #regulatorycompliance

The agenda is out now! Join us at the PDA Manufacturing Meets Legislation Workshop from 04-06 September 2024 in Berlin, Germany. This interactive workshop is designed to unite experts from the pharmaceutical industry and the legislative sector to address current challenges and share best practices in drug manufacturing in line with the latest legal regulations. This workshop will serve different topics in four modules: - Module 1: Preparation for EMA Inspectors Working Group Dialogue - Module 2: Impact of Planned PFAS Ban on the Pharmaceutical Industry in Europe with speakers from Eli Lilly, Merck, and Fraunhofer Institute - Module 3: Challenges and Opportunities in Pharmaceutical Manufacturing in Europe with experts from the EDQM, Merck, Tigen Pharma, West, and Vils - Module 4: Overview of the Current Changes in the EU Regulatory Framework with representatives from Amgen, Airfield, and the Green Innovation Group Be sure to register today! https://bit.ly/3wB3yC5

Check out Janeen Skutnik-Wilkinson discuss the value of the PDA/FDA Joint Regulatory Conference 2024!

Enhance your skills in aseptic filling! Join our comprehensive training course on aseptic filling, starting with EU GMP Annex 1 and regulatory requirements. Dive into barrier types, material transfer, and the importance of first air. Learn about primary packaging containers, filling technologies, and environmental risk analysis. Get hands-on experience with filling path installation, indirect product contact parts, and sterile filtration. - Understand Annex 1 requirements and barrier technologies. - Master the setup of filling paths and indirect contact parts. - Explore first-air considerations and filling line design. - Conduct environmental monitoring risk analysis. Limited space is available, so secure your spot today! 📅 04-05 September 📍 Training course venue: groninger Group facility in Crailsheim, Germany Supported by: Trainers from groninger Group, SKAN, Merck Life Science, PSM - Your Pharma CDMO, and STERIS Learn more and register: https://bit.ly/3RR2Wj6

Learn more about our Fundamentals of an Environmental Monitoring Program training! Get hands-on experience with environmental monitoring equipment and media, empowering you to develop a robust program tailored to your facility’s needs! During this course you will: - Learn about standards, surveillance support systems, and validation systems - Practice developing a surface and air environmental program for PDA’s cleanroom - Explore rapid micro method implementation - Dive into risk assessments and EMPQ creation - Receive a complimentary copy of the PDA Technical Report on this topic as an additional tool to take back to your organization Be proactive! Register now to ensure pharmaceutical product quality and safety: https://bit.ly/3VdwAQq #environmentalmonitoring #sterilityassurance #qualitycontrol

Dive into freeze drying at this five-day hands-on training course taking place at Martin Christ Gefriertrocknungsanlagen GmbH in Osterode am Harz, Germany! 📍 09-13 September Learn the ins and outs of freeze drying, also known as lyophilization, a crucial process for enhancing the stability of biopharmaceuticals. This comprehensive training will take you through the entire freeze-drying process, from freezing to primary and secondary drying. Reasons to attend: - Deep Dive into Freeze-Drying: Understand the structure, operating principles, key components of freeze-dryers, and remedies to system malfunctions. - Hands-On Learning: Engage in interactive training, exercises, and experiments in both lab and production settings. - Expert Guidance: Develop a freeze-drying recipe and troubleshoot system malfunctions with the help of experienced experts. - Technical Mastery: Learn about technical support, sensor calibration, system qualification, preventative maintenance, and automated loading/unloading systems. Limited space is available! Make sure to sign up today: https://bit.ly/3VMuSap #freezedrying #lyophilization #biopharmaceuticals

Master the essentials of aseptic processing with our comprehensive training course on 30-31 July in Berlin, Germany! Gain hands-on experience and deep insights into environmental monitoring, facility cleaning and disinfection, aseptic cleanroom operations, filtration, sterilization, and regulatory requirements. • Learn how to evaluate and improve current aseptic processing procedures. • Assess contamination risks with airflow visualization. • Develop effective environmental monitoring programs. • Understand the importance of filter integrity testing. • Ensure proper interventions in cleanroom fill operations. • Apply basic microbiology concepts to aseptic processing. • Master sanitization techniques and disinfectant evaluations. • Interpret regulatory requirements for sterile product manufacturing. Don’t miss this chance to elevate your aseptic processing skills and ensure product safety and compliance! Register now: https://bit.ly/3KivLRs

Don't forger to sign up for the FREE Validating Virtual Reality Training for Compliance in Pharma Webinar in collaboration with Innerspace - The Simulator Company! 📅 09 July 🕐 14:00-15:30 CEST As the pharma world embraces digital technologies, compliance with regulatory frameworks and validation of these solutions are crucial. Validating VR training approaches is a significant challenge, but once solved, it offers substantial benefits to people, the planet, and business profitability. Join us to learn from Linda Wildling (Takeda) and Markus Windisch (Innerspace) what a validated VR training approach under regulations like the CFR21 framework could look like and how VR can harmonize global training methods. Secure your spot: https://bit.ly/3VydiFS #pharma #VR

Taking place from 9 to 11 September in Washington, D.C., this FDA co-sponsored event is the premier pharmaceutical Current Good Manufacturing Practice (CGMP) conference in our industry. Attend to hear directly from Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research (CBER), U.S. FDA, and Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research (CDER), U.S. FDA. Now in its 33rd year, the conference will offer a comprehensive agenda with substantive sessions and practical case studies that will provide insight into the everyday application of CGMP and methodologies. Save up to 20% during our early registration period ending 17 July. Get more information and take an in depth look at the agenda: https://bit.ly/4eOt1cA #PDAFDA #FDA #CGMP

Introducing the GMP Comparison Workshop in Washington, DC! This hands-on workshop provides the essential regulations and information that will help in ensuring compliance with Current Good Manufacturing Practices(cGMP) in any country or region where sterile drug products are marketed. This workshop is based on the forthcoming revision of the PDA Global Sterile Manufacturing Guidance Comparison book. This document compares seven regulatory documents, including guidelines from U.S. FDA, the European Commission, WHO, PIC/S, Canada, Japan, and China. Workshop Highlights • Access invaluable information shared in the book and receive a free copy of the comparison tool to take back to your organization. • Dive into two action packed days filled with practical advice, real-world scenarios, and expert presentations. Participate in lively discussions, immersive case studies, and interactive role-playing exercises. • Learn how to build a robust training program and conduct an effective gap assessment, hear about significant misalignments across manufacturing guidances, and understand the impact of quality management systems on operations Don’t miss out on this highly educational and engaging workshop. Stay tuned for a sneak peek into the workshop and exclusive insights from the experts themselves! #PDAgmp #CGMP #asepticprocessing #pharma Check out the agenda: https://bit.ly/4eKBb5P